Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claims 1-5 are under consideration in the instant Office Action. Information Disclosure Statement The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. The information disclosure statements filed 4/18/2024 fail to fully comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because no copies for non-patent literature cited in the IDS were provided and the citations have therefore been lined through. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a). All references listed in the IDS that are not provided are lined through and not considered. Specification The use of the term s Thymoglobulin® and ATGAM® , which are trade name s or a mark used in commerce, has been noted in this application. The term s should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term . Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Claim Objections Claim 2 is objected to because of the following informalities: Claim 2 has a misplaced comma at: “ transgenic ungulate , 2, 3, …” which needs to be removed. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 2 calls for the administration of “the thymocytes to the transgenic ungulate 2, 3, 4, 5, or more times. ” It is unclear how many administrations are required because of the “5, or more times” since there is no set limit or range to indicate when the number of administered thymocytes is sufficient and it is unclear how an artisan would determine if, or when, they are infringing on the claimed invention due to indefinite metes and bounds . Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claim s 1-3 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Kacskovics et al., WO2015/036004 (IDS) . Kacskovics teaches methods of producing anti-thymocyte globulin (ATG). Kacskovics teaches polyclonal anti-thymocyte globulin produced in horse, goats and cows (aka bovine, see page 1, 2 nd paragraph, page 11, 3 rd paragraph, and page 9, 1 st paragraph) and reads on instant claim 1. Kacskovics teaches that the animals are immunized with human thymocytes see page 1, 2 nd paragraph) and reads on instant claims 1-3. Kacskovics teaches administering thymocytes 2 or more time and up to 4 times (see page 13, 2 nd paragraph) and reads on instant claim 2. Kacskovics teaches that this method produces immunoglobulin G (IgG) antibodies (see abstract and page 1, 1 st paragraph) and reads on instant claim 3. Kacskovics teaches methods on how to produce fully human antibodies for ATG (see paragraph spanning page 20-21) and reads on instant claims 1-3. Kacskovics teaches the ATG composition, which is made up of immunoglobulins, is harvested and purified (see page 23) and reads on instant claim 1 . Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim s 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kacskovics et al., WO2015/036004 (IDS) as applied to claim s 1-3 above, and further in view of Matsushita et al., 2015 (IDS). See Kacskovics, as discussed above. While Kacskovics teaches a transgenic ungulate to produce a polyclonal human anti-thymocyte globulin (ATC), Kacskovics fails to specifically teach the genes encoding the transgenic ungulate as required in instant claims 4-5. Matsushita teaches transgenic ungulates to produce l arge-scale production of fully human IgG (hIgG) or human polyclonal antibodies (see abstract) as in instant claim 1. Matsushita teaches h uman IgG1 class switch regulatory elements were subjected to site-specific genomic ch imerizati on on human artificial chromosome ( HAC ) vectors to further enhance hIgG expression and improve hIgG subclass distribution in cattle wherein these species-specific modifications in a chromosome scale resulted in much higher production levels of fully hIgG of up to 15 g/L in sera or plasma, the highest ever reported for a transgenic animal system (see abstract and page 2/30, 4 th paragraph) as in instant claim 4 . Matsushita teaches that the new HAC vectors in which the hIGHG1 gene class switch regulatory element, human Iγ1-Sγ1 (hIγ1-hSγ1) were bovinized (human sequences were replaced with bovine sequences ; see page 3/30 1 st paragraph ) as required in instant claim 5 . Matsushita teaches that t ranschromosomic (Tc) cattle containing engineered HAC vectors generated human polyclonal Abs with high titers against human-origin antigens following immunization (see abstract) . Matsushita does not specifically teach producing the AT G of instant claim 1. It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of Kacskovics and Matsushita . The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because Matsushita teaches that t ranschromosomic (Tc) cattle containing engineered HAC vectors generated human polyclonal Abs with high titers against human-origin antigens following immunization . One of ordinary skill in the art would use the ungulate transgenic model to produce the ATG as taught by Kacskovics to increase the production level of these polyclonal antibodies for human therapy and also overcome severe side effects such as allergic reactions (see page 2/30, 1 st paragraph). The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references. Conclusion No claims are allowed. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hooper et al., US201/0233459 (instant PTO-892) teaches methods of producing human polyclonal antibodies by immunizing transchromosomal ungulate animals [0004-0005]. Advisory Information Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURORA M. FONTAINHAS whose telephone number is 571-272-2952. The examiner can normally be reached on Monday - Friday (8AM - 4PM). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration t ool. To schedule an interview, a pplicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. /AURORA M FONTAINHAS/ Primary Examiner, Art Unit 1675